PBPK Modeling to Support Clinical DDI Studies

Physiologically based pharmacokinetic (PBPK) modeling to support the design of clinical drug-drug interaction (DDI) studies has continued to increase in NDA submissions for the last ten years. Both the FDA and EMA have strongly recommended that drug developers include PBPK modeling to support clinical DDI studies and have published guidance for regulating PBPK modeling. This webinar provides a detailed and in-depth demonstration of PBPK modeling approaches, summarizes the guidance and recommendations from regulatory agencies, describes the studies and experiments needed to develop models (including in vitro metabolism and ADME), identifies when PBPK modeling would be most beneficial or critical to include, and includes a case review.